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6 June 2023, Rockville, MD - The World Health Organization’s Prequalification Unit has approved zinc sulfate 20mg dispersible tablet, manufactured by Swiss Pharma Nigeria Limited (Swipha), which is based in Lagos, Nigeria. The approval marks the first pharmaceutical product and manufacturer to receive WHO Prequalification in West Africa.
Swipha received technical support from the United States Agency for International Development (USAID) funded Promoting the Quality of Medicines Plus (PQM+) as well as its predecessor program, implemented by the U.S. Pharmacopeia (USP).
Zinc sulfate is widely used, in concert with oral rehydration therapy, to treat diarrhoeal disease, the second leading cause of death in children under 5 years old. Approval by the WHO Prequalification Program indicates that this medicine meets acceptable standards of quality, safety and efficacy. WHO’s approval signals confidence in the quality of the zinc sulfate 20mg dispersible tablet manufactured by Swipha and enables, in principle, procurement by United Nations and donor organizations.
“We wish to express our profound appreciation to USAID and USP for the technical assistance, collaboration, and cooperation provided by PQM+ to our technical teams that has resulted in the WHO Prequalification of our zinc sulfate 20mg dispersible tablet,” said Mr. Abbas Sambo, Swipha’s Business Development and Licensing Director.
USP has collaborated with Swipha through USAID-funded programs since 2014. Through the PQM+ program, USP is currently working with 34 manufacturers in 11 countries to pursue WHO Prequalification or other regulatory approvals for 51 medical products.
“This milestone marks an important step in the advancement of pharmaceutical manufacturing capacity on the African continent,” notes PQM+ Director, Jude Nwokike. “It is yet another signal that Africa is capable of making more of its own medicines and medical products. USP is proud to be supporting manufacturers across the continent on their journeys toward the sustainable production of quality-assured products.”
The PQM+ program works to sustainably strengthen medical product quality assurance systems and helps ensure access to quality-assured essential medicines for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, COVID-19 and other infectious diseases as well as for maternal, newborn, and child health.
USP is an independent, international, and scientific nonprofit organization focused on building trust in the supply of safe, quality medical products. We are working to strengthen the global supply chain so the medical products people rely on for health are available when needed and work as expected. USP has 16 offices across 13 countries and implements global health programs in 50+ countries worldwide.